Osteoporosis Patient Education in Denmark

NCT05401968 | Completed

• 1 other identifier: 19/33410
• Study Type: interventional
• Target: 3,132
• Locations: 1 country
• Sites: 1

Brief Summary

In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.

Conditions

Osteoporosis

Keywords

Patient education

Outcome Measures

Primary Outcomes (2)

• Differences in quality of life between intervention and control group

  Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

• Differences in clinical diagnosis of fracture between intervention and control group

  Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

Secondary Outcomes (8)

• Differences in daily functional capacity between intervention and control group

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

• Differences in self-efficacy between intervention and control group

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

• Differences in psychological well-being between intervention and control group

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

• Differences in physical function between intervention and control group

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

• Differences in balance between intervention and control group

  At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

Study Arms (2)

Intervention group

EXPERIMENTAL

Osteoporosis patients who have participated in patient education

Behavioral: Osteoporosis patient education

Control group

NO INTERVENTION

Osteoporosis patients who have not participated in patient education

Interventions

Osteoporosis patient education BEHAVIORAL

During osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.

You may not qualify if:

• None though this may vary across municipalities

Sponsors & Collaborators

• University of Southern Denmark: lead
• National Research Center for Bone Health: collaborator

Study Sites (1)

National Institute of Public Health, University of Southern Denmark

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Holmberg

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Andersen

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Hitz

  National Research Center for Bone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The municipalities recruit and include citizens in osteoporosis patient education. We have already received information on participants from 2016 until 2020, and thereafter we will create a matched control group, who have not participated in osteoporosis patient education.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: September 19, 2022
• Primary Completion: December 31, 2022
• Study Completion: November 1, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)